Scientist/senior Scientist - Material Coordinator Epdm
AstraZeneca AB / Biomedicinjobb / Göteborg
2020-02-12
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hela Sverige AstraZeneca (AZ) is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we're more than one of the world's leading pharmaceutical companies. At AZ, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.
The arena
Pharmaceutical Sciences is accountable for the design and development of synthetic routes, preclinical and phase I/II drug product formulations, analytical methods and CMC project leadership needed to support early clinical trials, encompassing both small molecules and new modalities such as microRNA, messenger RNA and antisense oligonucleotides, across the whole range of AZ's therapeutic areas.
The manufacturing unit within Early Product Development and Manufacture (EPDM) in Gothenburg is accountable for manufacture of a large and variable portfolio of early investigational medicinal products (oral solution/suspension, parenteral solutions, capsules, tablets and inhalers), mainly for Phases I and II. We supply drug product to AZ clinical studies globally and are a vital part to enable early phase clinical trials, delivering a critical step on the path from idea to patient. In short, we are the first in line to manufacture what could improve the lives of patients around the globe
The role
Within the EPDM manufacturing unit, in the GMP arena, you will make an important contribution in delivering clinical results in the development of new medicines. This role entails coordination and management of materials used for product manufacture, ensuring reliable supply of materials and components that fulfil regulatory requirements and cGxP. The Role is a core enabler of manufacturing of drug product for AZ clinical studies and has a significant impact on the speed, quality and cost of the AZ development portfolio.
We expect the successful candidate to:
• Assume appointed accountability to ensure timely manufacture of numerous drug products in line with the plans agreed within EPDM.
• Proactively plan, coordinate and drive progress with regards to supply and simultaneously lead associated activities performed by assigned coworkers.
• Manage third party suppliers and associated systems to ensure timely delivery of raw materials
• Inventory management and set up for manufacture in associated systems - creation and approval of BOMs and Material Masters
• Quality control of incoming goods and ensure regulatory requirements are upheld with regards to material handling into our production facilities.
• Collaboration with internal and external partners and act as information relay between local planner, suppliers and incoming projects creating clarity in appointed areas of responsibility.
• Author manufacturing batch records together with other required documentation and setup transactions in material management systems.
• Monitor, secure and follow up on other regulatory requirements according to GMP through associated IT-systems.
• Ensure that SHE (Safety Health and Environment) and GMP standards are upheld on your end and ensure AZ Policies and Standards are understood and followed.
• Being entrepreneurial and drive initiatives and collaboration to further improve flexibility and productivity, all resulting in shorter lead times or increased value for our customers and stakeholder.
Experience/requirements
We are looking for a Scientist/Senior Scientist with excellent co-ordination, communication, and planning skills, balanced with the ability to work independently and drive performance and continuous improvements in appointed areas of material management. You will need a strong sense of delivery focus and thrive in being a vital cog in an efficient team ultimately delivering to patients.
We expect you to have a background in pharmacy, pharmaceutical sciences, engineering or proven experience in a related field within AZ or another business.
Excellent documentation skills, both in English and Swedish is a requirement. You will need proven record of collaboration and team work skills. We expect you to have a Proven record of IT/system skills and keen interest to learn new ones. Experience from working in a manufacturing or supply chain organisation and/or knowledge of cGxP is highly advantageous for this role.
More information
For more information about the position please contact Kim Stockfelt at +46 31 776 10 00 or Oskar Hedberg at +46 31 77 62673.
Welcome with your application (Including CV and a Personal Letter) no later than Monday the 24th of February 2020.
Varaktighet, arbetstid
Heltid Permanent
Publiceringsdatum2020-02-12ErsättningNot Specified
Så ansöker duSista dag att ansöka är 2020-02-22
Klicka på denna länk för att göra din ansökanFöretagAstrazeneca AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-074085".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 5093856
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